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NCT ID: NCT03248882 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

Start date: August 22, 2017
Phase: Phase 2
Study type: Interventional

Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

NCT ID: NCT03247946 Completed - Clinical trials for Feeding and Eating Disorders

The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity

Start date: September 13, 2010
Phase: N/A
Study type: Interventional

Does upright feeding position of 3 month old infants reduce respiratory and ear morbidity during the following year?

NCT ID: NCT03242252 Completed - Clinical trials for Type 2 Diabetes Mellitus

Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

SOTA-CKD3
Start date: August 16, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment. Secondary Objectives: - To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight. - To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.

NCT ID: NCT03242018 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

SOTA-CKD4
Start date: August 16, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: - To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c - To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo - To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo

NCT ID: NCT03241368 Completed - Crohn Disease Clinical Trials

Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease.

BLINK
Start date: December 21, 2017
Phase: N/A
Study type: Interventional

This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease. The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease. There will be assessment of mucosal disease activity at baseline. Patient satisfaction questionnaire will be completed at baseline.

NCT ID: NCT03240133 Completed - Clinical trials for Hereditary Angioedema (HAE)

Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema

Start date: July 31, 2017
Phase: Phase 2
Study type: Interventional

This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor, BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks) or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject diary entries completed at pre-defined times post-dose.

NCT ID: NCT03234712 Completed - Clinical trials for Advanced Solid Tumors Cancer

A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)

Start date: October 10, 2017
Phase: Phase 1
Study type: Interventional

This is an open-label, Phase 1, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-321 for participants with advanced solid tumors likely to overexpress the epidermal growth factor receptor (EGFR). The study will consist of 2 phases: Dose Escalation Phase and Expansion Phase.

NCT ID: NCT03234647 Completed - Acute Heart Failure Clinical Trials

First In Human Study of the Doraya Catheter for the Treatment of AHF Patients

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.

NCT ID: NCT03232398 Completed - Clinical trials for Acute Myocardial Infarction

Apixaban Versus Warfarin in Patients With Left Ventricular (LV) Thrombus

Start date: January 1, 2018
Phase: Phase 3
Study type: Interventional

Patients with acute ST-segment elevation myocardial infarction (STEMI) have an elevated risk of stroke, most of which are cardio-embolic in origin as a result of left ventricular (LV) thrombus formation. Anterior-wall location of a MI, in particular, can lead to the complications of LV aneurysm and/or thrombus, which some estimate occurs in approximately up to one-third of individuals within the first 2 weeks following an anterior MI. In the absence of anti coagulation, the risk of embolization in patients with a documented LV thrombus has been reported to be between 10 and 15 percent [3]. Although there are no randomized trials evaluating the efficacy of anticoagulation in patients with an LV thrombus after MI, observational studies provide substantial supporting evidence for the recommendation to anticoagulate patients with documented LV thrombus in order to reduce the risk of embolization. The observation that most events occur within the first three months from the MI forms the basis for the recommendation that anticoagulant therapy should be started early and continued for at least three to six months after myocardial infarction. Currently the practice guidelines recommend anticoagulation after MI only in certain settings such as the presence of LV thrombus or atrial fibrillation. To date there are no data on the use of novel oral anticoagulants (NOACS) for stroke prevention in the setting of LV thrombus after acute MI. The proposed aim of this randomized open label non inferiority clinical trial is to assess whether apixaban is as effective as VKA for the treatment of LV thrombus after acute ST segment elevation MI. Population: Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) 3 to 7 days post admission for acute ST-elevation MI Intervention: The patients will be randomly assigned to treatment with apixaban or s.c enoxaparin 1mg/Kg BID followed by dose-adjusted warfarin to achieve a target international normalized ratio (INR) of 2.0 to 3.0 for 3 months. The study Outcomes are the presence of LV thrombus as assessed be echo, major bleeding, and stroke or systemic embolism and death from any cause.

NCT ID: NCT03232073 Completed - Multiple Sclerosis Clinical Trials

Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis

OPTIMUM-LT
Start date: July 5, 2017
Phase: Phase 3
Study type: Interventional

The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.